- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00128882
Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background:
Idiopathic thrombocytopenic purpura (ITP) in children is considered a benign hematological disease. The incidence is approximately 50 cases a year in Denmark. Approximately 25 % will experience chronic disease. Follow up and treatment of these patients is not centralized.
The drug of choice is intravenous IgG (IVIG) for treatment of ITP. The side effects are flu-like symptoms, and in rare cases aseptic meningitis. Another option is intravenous anti-D, if the child is rhesus positive. Anti-D is primarily used in North America. The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50,000/μL. Anti-D also causes flu-like symptoms. Establishing an i.v. access is a disadvantage to both IVIG and anti-D. For both treatments mechanism of action is not finally described.
Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia. It is therefore known, that immunoglobulin uptake is possible after subcutaneous administration. Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results.
IVIG treatment is expensive compared to anti-D. Treatment of a 20 kg child costs approximately 17,000 Dkr for IVIG and 2,500 Dkr. for anti-D.
Hypothesis:
- Subcutaneous administered anti-D is as effective as IVIG/i.v. anti-D;
- Subcutaneous administered anti-D has fewer less severe side effects than IVIG/i.v. anti-D.
Purpose:
- To document the effect of subcutaneous anti-D;
- Describe complications;
- Describe aspects of the mechanism of action.
Material and Methods:
Children are eligible if admitted to a pediatric department in Denmark for diagnosis, observation or treatment of acute or chronic ITP. Examination and diagnostic work up is similar throughout the country, but not identical. No specific tests are required for diagnosis. If treatment is indicated rhesus positive children are treated with subcutaneous anti-D. Rhesus negative children are treated according to local guidelines. Specified follow-up on all children is mandatory. For research purposes one blood sample form all children is collected, and from children, who receive medical treatment, several blood samples are collected. Analysis for changes in immunological signaling peptides will be performed with special attention to the mechanism of action of anti-D.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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-
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Aalborg, Danemark, 9100
- Aalborg University Hospital, Department of Pediatrics
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Aarhus N, Danemark, 8200
- Skejby Hospital, Aarhus University Hospital, Department of Pediatrics
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Copenhagen S, Danemark, 2300
- Amager Hospital, Department of Pediatrics
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Copenhagen Ø, Danemark, 2100
- Rigshospitalet, Copenhagen University Hospital, Pediatric Clinic II
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Esbjerg, Danemark, 6700
- Esbjerg Hospital, Department of Pediatrics
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Gentofte, Danemark, 2900
- Gentofte Hospital, Department of Pediatrics
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Herning, Danemark, 7400
- Herning Hospital, Department of Pediatrics
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Hjoerring, Danemark, 9800
- Hjoerring Hospital, Department of Pediatrics
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Holbæk, Danemark, 4300
- Holbæk Hospital, Department of Pediatrics
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Hvidovre, Danemark, 2650
- Hvidovre Hospital, Department of Pediatrics
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Kolding, Danemark, 6000
- Kolding Hospital Department of Pediatrics
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Nykøbing F, Danemark, 4800
- Nykøbing F, Department of Pediatrics
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Næstved, Danemark, 4700
- Næstved Hospital, Department of Pediatrics
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Odense C, Danemark, 5000
- Odense University Hospital
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Randers, Danemark, 8900
- Randers Hospital, Department of Pediatrics
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Sønderborg, Danemark, 6400
- Sønderborg Hospital, Department of Pediatrics
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Viborg, Danemark, 8800
- Viborg Hospital, Department of Pediatrics
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Idiopathic thrombocytopenic purpura (ITP)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Clinical effect evaluated on clinical score scale before and after treatment at specified intervals
Délai: day 0,1,3,6,14,30, 180,360
|
day 0,1,3,6,14,30, 180,360
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Platelet count
Délai: day 0, 1, 3, 6, 14, 30, 180, 360
|
day 0, 1, 3, 6, 14, 30, 180, 360
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Mimi Kjaersgaard, MD, University of Aarhus, Clinical Institute, Department of Pediatrics
- Chercheur principal: Henrik Hasle, MD PhD, Skejby Hospital, University of Aarhus, Department of Pediatrics
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies hématologiques
- Hémorragie
- Troubles hémorragiques
- Troubles de la coagulation sanguine
- Manifestations cutanées
- Thrombocytopénie
- Troubles des plaquettes sanguines
- Microangiopathies thrombotiques
- Purpura
- Purpura thrombocytopénique
- Purpura, thrombocytopénique, idiopathique
Autres numéros d'identification d'étude
- MK-2005-1
- 2003179
- 2612-2447
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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